The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939107
• Other study ID #: KF-01-057/03
• Status: Completed
• Phase: N/A
• First received: July 13, 2009
• Last updated: November 9, 2009
• Start date: September 2003
• Est. completion date: November 2008

Study information

• Verified date: November 2009
• Source: Back and Rehabilitation Center, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Introduction:

The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.

Methods:

After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.

Description:

In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18 to 60 years of age

• suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks

• able to speak and understand the Danish language

• with a presentation of clinical signs of disc-related symptoms.

Exclusion Criteria:

• positive non-organic signs

• serious pathology suspected based on physical examination and/or magnetic resonance imaging

• application for disability pension or pending litigation

• pregnancy

• comorbidity

• recent back surgery

• problems with communication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• spinal manipulation
Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
• McKenzie exercises
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy

Locations

Country	Name	City	State
Denmark	Back and Rehabilitation Center Copengagen	Copenhagen	Copenhagen OE

Sponsors (5)

Lead Sponsor	Collaborator
Back and Rehabilitation Center, Copenhagen	Foundation for Chiropractic Research and Post Graduate Education, The Danish Institute for Mechanical Diagnosis and Therapy., The Danish Physiotherapy Organization., The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability		two months after treatment	No
Primary	Number of Patients With Treatment Success		Two months posttreatment	No
Secondary	Pain		twelve months posttreatment	No
Secondary	Number of Patients on Sick Leave		twelve months posttreatment	No
Secondary	Quality of Life		twelve months posttreatment	No
Secondary	Cost Effectiveness		twelve months posttreatment	No